Systems and methods for tissue treatment

ABSTRACT

A system, delivery device and method delivers ultrasonic energy to a target musculoskeletal tissue site. In some embodiments, the delivery device includes a monolithic stainless steel needle and horn.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. application Ser. No.15/716,278, filed Sep. 26, 2017, which is a continuation of U.S.application Ser. No. 14/866,472, filed Sep. 25, 2015, now U.S. Pat. No.9,770,257, which is a continuation of U.S. application Ser. No.13/493,851, filed Jun. 11, 2012, now U.S. Pat. No. 9,149,291. Thedisclosure of each of these applications is incorporated herein byreference in its entirety.

BACKGROUND

Repetitive motion or use of particular body tissues can cause injuriesor painful conditions to arise. For example, tennis elbow, or lateralepicondylalgia is a clinical syndrome in which patients experience painat the lateral elbow. Such pain in the lateral elbow may be worsen overtime and, despite adequate treatment, many patients develop chronicsymptoms and eventually become candidates for surgical treatment.

A number of surgical procedures have been described to treat chronictendonosis or fasciitis affecting any region in the body. Particularopen techniques typically require open surgical dissection down to thepathological tissue and therefore necessitate repair of the surgicallycompromised normal tissue. Some arthroscopic techniques can be slightlyless invasive, but these arthroscopic elbow techniques have beenassociated with neurological complications and may require the use of ahigh-cost operating suite and associated personnel. Various percutaneoustechniques have been described which release, ablate or resect thepathological tissue. These percutaneous techniques, however, generallyrequire a noticeable skin incision, some surgical dissection, and theafore-mentioned use of a high-cost operating suite and supportiveequipment and personnel.

Accordingly, a need exists for the further development of systems forminimally invasive tissue treatment.

SUMMARY

In some embodiments, the system, delivery device and method deliversultrasonic energy to a target musculoskeletal tissue site. In someembodiments, the delivery device includes a stainless steel needlejoined to a horn. The stainless steel needle may be joined to the hornusing a heating process or a brazing process.

In certain embodiments, the needle and horn comprise a single monolithiccomponent, wherein the single component is produced, for examplemachined, for example from stainless steel such as precipitationhardened stainless steel. Disclosed embodiments comprise a monolithicultrasonic horn and needle design, for example machined fromprecipitation hardened stainless steel, configured to receive energygenerated by a transducer; a bearing surface on the proximal end of theultrasonic horn-needle to achieve necessary mechanical coupling with thetransducer, and maintain it along the entire part length, also achievingnecessary gain and associated tip displacement at the distal end of thehorn-needle

Some embodiments relate to a system for musculoskeletal tissue treatmentunder ultrasonic guidance. The system may include a delivery device anda controller configured to deliver a power signal to the deliverydevice. The delivery device may include a housing portion, a transducer,and a stack assembly.

In some embodiments, the housing and the stack assembly may defineportions of an aspiration conduit and an irrigation conduit.

In some embodiments, the delivery device includes a horn assembly, forexample a horn assembly comprising a needle, which receives ultrasonicenergy and delivers the ultrasonic energy to the musculoskeletal tissuesite.

Additional features and advantages are described herein, and will beapparent from the following Detailed Description and figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one example embodiment of the systemdisclosed herein.

FIG. 2 is a perspective view of one example embodiment of the deliverydevice disclosed herein, illustrating an example extension and anexample tab.

FIG. 3 is a perspective view of one example embodiment of the stackassembly, illustrating the horn assembly, the crystal stack assembly andthe compressor.

FIG. 4 is an enlarged perspective view of one example of the horn,illustrating the horn having a groove portion and a slanted tip portion.

FIG. 5 is a longitudinal section of a portion of the horn assembly,illustrating the slanted tip portion having an angle of about 135°.

FIG. 6 is a perspective view of one example of the horn assembly,illustrating the horn having an opening for connecting to the mountingmember.

FIG. 7 is a perspective view of one example of the horn assembly,illustrating the horn assembly being connected to the mounting member.

FIG. 8 is a perspective view of one example of the crystal stackassembly, illustrating the crystal stack assembly having piezoelectriccrystals and electrodes.

FIGS. 9A and 9B are perspective views of one example of the compressor,illustrating the compressor defining a lumen and having a barbedfitting.

FIG. 10 is a cross-sectional view of one example of the delivery device,illustrating the irrigation conduit and the vacuum conduit.

FIG. 11 is a schematic view of one example of the controller,illustrating the command module, the use interface and the tubingcassette.

FIG. 12 is a schematic view of one example of the user interface of thecontroller.

FIGS. 13A, 13B and 13C are alternative views of one example tubingcassette of the controller.

FIG. 14 illustrates a diagrammatic view of one example of the systembeing used in conjunction with ultrasound imaging system to deliverultrasonic energy to a target musculoskeletal tissue site underultrasonic imaging.

DETAILED DESCRIPTION

Various embodiments described herein provide systems for accessing andtreating target body tissue (e.g., tendon tissue, ligament tissue,muscle tissue, bony tissue, and the like) under guidance of ultrasoundimaging equipment. In some embodiments, the system includes a deliverydevice having a stainless steel type needle brazed to a horn using aheating process or brazing process. The brazing or heating processesdescribed herein may allow for an increase in the length of thestainless steel type needles which may be used by a delivery device foraccessing and treating target body tissue. In some embodiments, theneedle and horn comprise a single monolithic component, wherein thesingle component is machined, for example from stainless steel, forexample precipitation hardened stainless steel.

FIG. 1 illustrates an example system according to an example embodimentof the present disclosure which is configured to percutaneously accessand act upon target tissue while helping reduce collateral trauma. Insome example embodiments, the minimally-invasive ultrasonic nature ofsystem 100 increases the accuracy of removing diseased tissue whencompared to surgical procedures which include surgical dissections ofhealthy tissue. In some embodiments, the percutaneous,minimally-invasive nature of system 100 facilitates treatment of apatient in an office setting under local anesthesia. Treatment in anoffice setting is advantageous in several respects, for example,including patient comfort and convenience and avoiding costs associatedwith operating room time and general anesthesia.

In some embodiments, as best illustrated in FIGS. 1 and 14, system 100includes delivery device 102 and controller 104 which is operativelyconnected delivery device 102.

In some embodiments, as illustrated in FIG. 1, delivery device 102 isoperatively connected to controller 104 via power line 106, vacuum line108 and irrigation line 110.

Power line 106 may connected to controller 104 via a wired connection asshown in FIG. 1. In another embodiment, controller 104 may be configuredto communicate with delivery device 102 via a wireless communication ora combination of a wired communication and a wireless communication.

In some embodiments, delivery device 102 is configured to transmitultrasonic energy to a percutaneous musculoskeletal site at a pre-tunedfrequency selected to debride musculoskeletal tissue. As bestillustrated in FIGS. 1 to 3, in some embodiments, delivery device 102includes: (a) housing 112; and (b) stack assembly 138. In someembodiments, delivery device includes cap 114.

In some embodiments, housing 112 includes at least two separateportions. For example, as illustrated in FIG. 2, housing 112 includeincludes: (a) nose portion 116; (b) body portion 118; and (c) tailportion 120.

In some embodiments, as discussed in more detail below, the housingincludes a portion configured to form part of an irrigation conduit. Forexample, as best illustrated in FIGS. 2 and 10, nose portion 116includes portion or sleeve 117. In this example, sleeve 117 defines aninner lumen or channel which forms part of an irrigation conduit.

In some embodiments, sleeve 117 has an insertion portion 121 whichextends to a terminal end and is adapted for percutaneous insertion.

Insertion portion 121 of sleeve 117 may be any suitable size. In someexample embodiments, insertion portion 121 has a size of about twelvegauge or less, about twelve gauge to about twenty-five gauge, or aboutfourteen gauge to about twenty-two gauge.

Insertion portion 121 may have a lateral width of any suitable size. Insome example embodiments, insertion portion 121 has a lateral width ofabout 2.5 mm or less, about 2.2 mm to about 0.4 mm, or about 2.1 mm toabout 0.5 mm.

The length of insertion portion 121 may be any suitable size. In someexample embodiments, the length of insertion portion 121 is about threeinches to about 0.25 inches, about 2.7 inches to about 0.5 inches, orabout 2.5 inches to about 1.0 inch.

In some embodiments, the terminal end of insertion portion 121 is formedwith a sharp angle or in other embodiments is squared off.

Insertion portion 121 may leave the exposed portion of needle 136 at anysuitable length. In some embodiments, insertion portion 121 may leavethe exposed portion of needle 136 at a length of about 10 mm or less,for example between from 2 mm to about 10 mm.

In some embodiments, as best illustrated in FIGS. 2 and 10, sleeve 117may be integrally formed as part of nose portion 116. In anotherembodiment, needle sleeve 117 is separate from and connects to noseportion 116.

Sleeve 117 may be formed of an echogenic, biocompatible materialsuitable for dampening products of ultrasonic energy (e.g., heat andvibration). In some embodiments, sleeve 117 is coated with an echogenicmaterial. In some embodiments, sleeve 117 is formed of a materialexhibiting a differential echogenicity to that of needle 136. In suchembodiments, both needle 136 and sleeve 117 facilitate ultrasonicimaging and separate identification during percutaneous insertion.

In some embodiments, nose portion 116 is configured to function as aguide for needle 136 during ultrasonic vibration.

In some embodiments, as illustrated in FIG. 10 and discussed in moredetail below, nose cone portion 116 defines channel 119 for enablingand/or directing fluid flow into an incision site. The fluid flow mayremove any heat buildup due to friction.

In some embodiments, to prevent air from being delivered to amusculoskeletal tissue site from the irrigation conduit, system 100 isconfigured to evacuate air from the irrigation conduit. Nose portion 116may be formed from substantially clear material which allows a user todetermine whether any air bubbles exist in the irrigation conduit.

In some embodiments, housing 112 may define a portion to facilitate aconnection to irrigation line 110. For example, as best illustrated inFIG. 2, body portion 118 defines extension 130 which enables deliverydevice 102 to connect to irrigation line 110. In some embodiments, asbest illustrated in FIGS. 2 and 10, extension 130 defines a hollow lumenhaving an inlet.

Extension 130 may be configured such that irrigation line 110 slidesover the outer surface of extension 130. The outside surface ofextension 130 may have a luer type taper on the outside surface ofextension 130 which is configured to connect to irrigation line 110.

Extension 130 may have any suitable shaped cross section, such as, forexample, a cylindrical cross section or a substantially square-shapedcross section. In this example, extension 130 forms part of theirrigation conduit. In another example, extension 130 may have a barbfitting to connect to irrigation line 110.

In some embodiments, extension 130 may be referred to as a tube fitting.

As illustrated in FIGS. 2 and 10 and discussed in more detail below, insome embodiments, tail portion 120 defines opening 128 which allowsvacuum line 108 and power line 106 to connect to delivery device 102.

In some embodiments, housing 112 has a substantially cylindrical-shapedcross section. In other embodiments, housing 112 may a different shapedcross section, such as, for example a substantially square-shaped crosssection.

The above-described separate portions of housing 112 may be configuredto connect to each other using any suitable method. For example, in someembodiments, using glue, nose portion 116 may be configured to mate withand connect to a first end of body portion 118, and tail portion 120 maybe configured to mate with and connect to the opposite end of bodyportion 118.

Housing 112 may be formed of any suitable material including moldedplastic and/or Acrylonitrile Butadiene Styrene.

In an embodiment where housing 112 is designed to include separateportions such as the portions described above, this design may provide acost effective method for producing a low cost ultrasonic hand piece.

Cap 114 may be configured to be removably connected to housing 112. Forexample, FIG. 1 illustrates cap 114 being connected to nose portion 116,and FIG. 2 illustrates cap 114 being removed from nose portion 116. Insome embodiments, cap 114 is configured to removably connect to noseportion 116 by employing a luer taper interface.

In some embodiments, cap 114 is configured to seal the fluid system ofsystem 100. Such a configuration enables system 100 to be primed andprepared for surgery.

In some embodiments, as best illustrated in FIGS. 3 to 9B, stackassembly 138 includes: (a) horn assembly 140; (b) crystal stack assembly142; and (c) compressor 168.

In some embodiments, delivery device 102 includes a mounting member. Forexample, as illustrated in FIGS. 7 and 10, delivery device 102 includesmounting member 152.

In some embodiments, horn assembly 140 is configured to connect tomounting member 152. For example, as illustrated in FIG. 6, in oneembodiment, opening 150 may define a threaded portion which isconfigured to mate with and connect to a threaded portion of mountingmember 152. FIG. 7 illustrates one example of mounting member 152 beingconnected to horn assembly 140. It should be appreciated that hornassembly 140 may connect to mounting member 152 in any suitable manner.

In some embodiments, horn assembly 140 includes mounting member 152.That is, in these embodiments, mounting member 152 is not a separatecomponent of horn assembly 152, but rather is formed as a single,integral component of horn assembly 152. For example, horn 144 andmounting member may be formed as a single component.

In some embodiments, horn assembly 140 includes: (a) needle 136; and (b)horn 144.

In some embodiments, needle 136 is a generally hollow tubular memberwhich defines a lumen. As illustrated in FIGS. 3, 6, 7 and 10, needle136 may have distal portion 137 and proximal portion 139.

Distal portion 139 is preferably adapted for percutaneous insertion.Distal portion 139 may be formed at a sharp angle or may be squared off.In some embodiments, distal portion 139 may have serrated edges or othersurface features for enhancing ultrasonic debridement.

In some embodiments, needle 136 is covered or coated with echogenicmaterial.

Distal portion 137 may have any suitable size. In some exampleembodiments, distal portion 137 has a size of about 12 gauge or less,about 12 gauge to about 25 gauge, or about 14 gauge to about 22 gauge.

Distal portion 137 has a lateral width of any suitable size. In someexample embodiments, display portion 137 has a lateral width of about2.5 mm or less, about 2.2 mm to about 0.4 mm, or about 2.1 mm to about0.5 mm.

The length of distal portion 137 may be any suitable size. In someexample embodiments, the length of distal portion 137 is about threeinches to about 0.25 inches, about 2.7 inches to about 0.5 inches, orabout 2.5 inches to about one inch.

In some embodiments, needle 136 is formed of an echogenic, biocompatiblematerial suitable for conveying ultrasonic energy. For example, needle136 may be formed of a stainless steel alloy. In some embodiments,needle 136 may include a stainless steel hypodermic needle. In someembodiments, needle 136 may be formed from a 174 precipitant hardenedstainless steel. In some embodiments, needle 136 includes a heathardened stainless steel. In some embodiments, needle 136 includes awork hardened stainless steel, such as 300 stainless steel.

In some embodiments, needle 136 may have a forty-five degree bevel tofacilitate insertion into the surgical site.

In some embodiments, as best illustrated in FIGS. 2 and 10, sleeve 92and needle 136 are positioned such that needle 136 has a covered portionand an exposed portion.

In some embodiments, sleeve 117 may be configured to reduce unwanted,collateral transmission of heat, ultrasonic energy, or other byproductsof the ultrasonic energy being conveyed along the covered portion ofneedle 136. Sleeve 117 may reduce or eliminates damage to non-targetbody tissues as a result of unwanted transmission of ultrasonic energy.

In operation, needle 136 vibrates at the surgery site and breaks upcertain tissue up such as scarred tendon tissue, osteophytes, andcalcifications. Needle 136 may configured to direct the aspiration flowfrom the bore of needle 136 back to collector 192.

In some embodiments, horn 144 is configured to compress piezoelectriccrystals and amplify ultrasonic vibration.

In some embodiments, horn 140 may have a tip portion configured toenable or allow for a more durable connection between horn 140 andneedle 136. For example, as illustrated in FIGS. 4 and 5, horn 140 hastip portion 145. In this example, tip portion 145 defines slant portion147 having an angle (“θ”). In one example, θ is about 135°. Slantportion 147 enables for a more durable connection between horn 140 andneedle 136. In this example, slant portion 147 slants inwardly. In thisexample, this cupped-shaped portion allows for the brazing material topool into said portion.

In some embodiments, horn 144 defines an opening to connect to othercomponents of delivery device 102. For example, as illustrated in FIG.6, horn 140 defines opening 150 which enables horn 140 to receivemounting member 152. In one example, mounting member 152 connects tohorn 144 via a threaded connection. It should be appreciated thatmounting member 152 may connect to horn 144 in any manner.

In some embodiments, as described above, horn assembly 140 includes horn144 and needle 136. In other embodiments, horn assembly 140 includeshorn 144, needle 136 and mounting member 152. In one embodiment, horn144 and mounting member 152 are formed as a single integral component.

Horn 144 may be made of a metal such as stainless steel. In someembodiments, both horn 144 and needle 36 are made of only stainlesssteel. In embodiments, horn and needle comprise a single component, forexample a monolithic single component made of stainless steel.

In some embodiments, mounting member 152 defines a bore or lumen whichforms a portion of the vacuum conduit and directs aspiration flow fromhorn assembly 140 to a lumen defined by compressor 168.

In some embodiments, mounting member 152 is made from titanium, whichmay allow for stack assembly 138 to resonate at a proper frequency(e.g., between 25 KHz and 30 KHz).

Mounting member 152 may be frictionally fit, adhered, welded, orotherwise secured within housing 112.

In some embodiments, crystal stack assembly 142 is disposed aroundmounting member 152.

In some embodiments, using a material (e.g., a brazing material), needle136 is connected to horn 140 by employing a brazing process or a heatingprocess. During the brazing process, the brazing material melts thebrazing material to cause needle 136 to join together with horn 144 toform a single contiguous horn assembly. The melting temperature of thebrazing material alloy is preferably low enough such that needle 136will not anneal during the brazing process. The melting temperature ofthe brazing material facilitates fixing the needle to the horn. In someembodiments, the needle and horn form a monolithic single component.

In some embodiments comprising separate horn and needle component,during the brazing process, needle 136 may be in a condition that can beaffected by an elevated temperature. If needle 136 anneals during abrazing process or heating process, then strength of needle 136 isreduced, and needle 136 will likely break during ultrasonic vibration.Because needle 136 cannot anneal, needle 136 cannot be brazed to horn144 in a vacuum braze environment.

In some embodiments comprising separate horn and needle component, usingthe brazing process described herein, needle 136 may be brazed to horn144 such that needle 136 will not annealed during the brazing or heatingprocess.

For example, in one example, needle 136 and horn 144 may be formed ofstainless steel. In this example, needle 136 and horn 144 may be joinedtogether using an acid flux and inert gas (e.g., nitrogen) to facilitatethe braze material flow during the brazing process. In some embodiments,needle 136 is brazed to horn 144 using an induction brazing machinewhich employs heat generated from an electromagnetic field created bythe alternating current from an induction coil. In some embodiments, thebraze joint is protected against oxidation by placing a tube over thebraze joint. After the tube is placed over the brazed joint, gas may beadded. In some embodiments, an additive (e.g., acid flux) may be used tobreak surface tension of the metal of the needle and the horn.

In embodiments, the monolithic needle-horn assembly is formed of, forexample, steel, such as stainless steel.

In some embodiments comprising separate horn and needle component, thebrazing or heating processes described herein may increase the sizes ofthe stainless steel type needles which may be used by a delivery deviceto function properly. In certain delivery devices having certain typesof stainless steel needles attached to a horn, the stainless steelneedle may break based on the needle's strength. For example, where astainless steel needle has a length of about twenty-two times thediameter of the bore diameter, it has been found that themanufacturability decreases and the costs substantially increase.Although, a titanium type needle may be used in certain situations toincrease the length of the needle, a titanium type needle issignificantly more expensive than a stainless steel type needle. Usingthe brazing or heating procedure described herein, delivery device 102may include a stainless steel needle having a length of about onethousand times the diameter of the bore. Such a configuration mayprovide for reduced cost of delivery device 102 by eliminatingcomponents typically used in the construction of a delivery device(e.g., a titanium needle).

In some embodiments, the brazing material may include an alloy, nickel,silver, copper and/or a silver based alloy perform.

In some embodiments, the brazing material is supplied as a preformeddonut shape, similar to braze ring 146 illustrated in FIGS. 3, 6, 7 and10. In some embodiments, the brazing material to supplied as a wirewhich may have, for example, a 1/32″ diameter.

The brazing material may have a high density. In some embodimentscomprising separate needle and horn components, the brazing material hasa higher density than needle 136 and horn 144. In these embodiments,horn 144 may be tuned to different resonant frequencies based on thevolume of braze material applied. For example, in one embodiment, system100 includes a 27 KHz drive signal generator. In this example, themechanical system may have to resonate between 25 KHz and 29 KHz tofunction properly. If it is determined that stack assembly 138 isresonating at 31 KHz, stack assembly 138 will not function properly. Inthis example, adding more brazing material can reduce the resonatingfrequency of stack assembly 138, and therefore enable stack assembly 138to function properly.

In some embodiments comprising separate needle and horn components,needle 136 is a fully hardened hypodermic needle which is brazed to horn144.

In some embodiments comprising separate needle and horn components,needle 136 is connected to horn 144 using a brazing material includingsilver because silver has a melting point below the annealing point ofstainless steel.

In some embodiments comprising separate needle and horn components,needle 136 is not directly connected to horn 144. For example, needle136 may be connected to a component which is connected to horn 144. Inthese embodiments, needle 136 may be described as being operativelyconnected to horn 144. However, it should be understood that whereneedle 136 is directly connected to horn 144, needle 136 may bedescribed as being operatively connected to horn 144 also.

In one example embodiment comprising separate needle and horncomponents, by brazing needle 136 horn 144, the system described hereinmay function properly with needle 136 having a length of threes inchesand a bore size of 0.035 inches.

In some embodiments, crystal stack assembly 142 includes a transducerwhich is configured to generate ultrasonic energy based on a powersignal. For example, as illustrated in FIG. 8, crystal stack assembly142 includes a transducer which is configured to generate ultrasonicenergy based on a power signal which is provided from controller 102.The ultrasonic energy may be applied in a pulsed fashion or continuousfashion.

In some embodiments, the transducer includes piezoelectric crystals. Forexample, as illustrated in FIG. 8, the transducer includes: (a) firstpiezoelectric crystal 154; (b) second piezoelectric crystal 156; (c)third piezoelectric crystal 158; and (d) fourth piezoelectric crystal160. In this example, the transducer is operatively connected to: (a)first electrode 162; (b) second electrode 164; and (c) third electrode166.

In some embodiments, the transducer is mounted to mounting member 152such that ultrasonic energy generated by the transducer is transferredto horn assembly 140.

The transducer may be configured to generate longitudinal vibration,transverse vibration, or combinations thereof at desired frequencies.For example, the number and configuration of the piezoelectric crystalsmay be varied to modify the ultrasonic frequency used for tissuetreatment.

As illustrated in FIG. 8, in some embodiments, crystal stack assembly142 may include four piezoelectric crystals. In other embodiments,crystal stack assembly may include at least two piezoelectric crystals.

In some embodiments, as illustrated in FIG. 8, the piezoelectriccrystals may be donut-shaped.

In some embodiments, as illustrated in FIGS. 8 and 10, the piezoelectriccrystals may be configured to receive mounting member and be positionedover mounting member 152.

In some embodiments, the piezoelectric crystals and electrodes arecompressed between horn assembly 140 and compressor 168.

The piezoelectric crystals may be assembled such that the polarizationsare aligned.

In some embodiments, portions of the electrodes are sandwiched betweenthe piezoelectric crystals. In some embodiments, the electrodes supplythe electric charge to cause these crystals to vibrate.

In some embodiments, as best illustrated in FIG. 8, the ends ofelectrodes 162, 164 and 166 have a crimping feature which allows forcrimping wires to create an electromechanical connection. This type ofconnection is typically a solder connection. Such a configuration allowsfor assembly in a clean room without having soldering fumes or acid fluxclean up.

In some embodiments, the electrodes include a positive electrode whichhas a portion that jumps between the positive polarities of thecrystals.

In some embodiments, the electrodes include negative electrodes whichcreate a safety ground loop circuit.

In some embodiments, the negative electrodes are placed between the flatsurfaces of the crystals. In these embodiments, the negative electrodesmay contact the metal components of the stack to complete the groundcircuit.

In some embodiments, compressor 168 is configured to provide compressionforce for crystal stack assembly 142. Compressor 168 may be torqued to apredetermined value to achieve a specific crystal compression.

As illustrated in FIGS. 3, 9A, 9B and 10, in some embodiments,compressor 168 may have first end portion 172 and second end portion174. In some embodiments, compressor 168 defines opening or bore 170which runs from first end portion 172 to second end portion 174. Opening170 may be used for directing the aspiration flow to the vacuum line108.

In some embodiments, compressor 168 may connect to mounting member 152using any suitable connection method. In some embodiments, first endportion 172 of compressor 168 is connected to mounting member 152 via athreaded connection.

Compressor 168 may include fitting configured to connect to vacuum line108. For example, as illustrated in FIGS. 3 and 10, compressor 168includes barb fitting 169 which is configured to connect to vacuum line108. In this embodiment, barb fitting 169 is integrally formed withcompressor 168. In another embodiment, barb fitting is separate from andoperably connects to compressor 168. Barb fitting 169 may provide aninterference fit with vacuum line 108. Barb fitting 169 may provide forreduced cost of delivery device 102 by eliminating components typicallyused in the construction of a delivery device.

In some embodiments, compressor 168 may be referred to as a compressionnut.

In some embodiments, delivery device 102 includes an irrigation conduitwhich enable delivery device 102 to deliver fluid to a musculoskeletaltissue site.

As illustrated in FIG. 10, in some embodiments, the irrigation conduitmay be formed by portions of (a) housing 112; and (b) horn assembly 140.More specifically, in some embodiments, the irrigation conduit mayformed such that fluid may be passed from the inlet of extension 130,through channel 119 of nose portion 112 and out of sleeve 117 of noseportion 116.

In some embodiments, as best illustrated in FIG. 10, needle 136 andsleeve 92 are secured relative to one another, with needle 136 disposedin the inner lumen of sleeve 92, needle 136 and sleeve 92 define a gapbetween them to form a portion of the irrigation conduit.

In some embodiments, an outlet from the irrigation conduit may bedefined between the terminal end of sleeve 92 and needle 136. Thus,fluid passing into the irrigation conduit in a distal direction passesfrom the irrigation conduit with fluid generally encircling, orcircumscribing the insertion portion of needle 136 and being directedtoward the exposed portion of needle 136.

In some embodiments, delivery device 102 includes a vacuum conduit whichenables delivery device 102 to remove detritus from the musculoskeletaltissue site.

Referring to FIG. 10, the vacuum conduit may be formed by the lumenportions of: (a) horn assembly 140; (b) mounting member 152; and (c)compressor 138. As illustrated in FIG. 10, the vacuum conduit may beformed by lumens formed in needle 136, horn 144, mounting member 152 andcompressor 168.

The vacuum conduit may pass through the transducer as shown in FIG. 10.

In some embodiments, as illustrated in FIG. 10, delivery device 102includes gasket or O-ring 216. In these embodiments, gasket 216 isconfigured to fit into groove portion 148 of horn 144. Such aconfiguration creates a seal between housing 112 and horn 144 such thatfluid within the inner compartment formed by nose portion 116 isprevented from entering within body portion 118 and fluid may bedelivered through the irrigation conduit.

As illustrated in FIG. 10, delivery device 102 may include gasket 216disposed between body portion 118 and nose portion 116. In someembodiments, during assembly of delivery device 112, body portion 118may slide over stack assembly 138 up to and engage gasket 216.

In some embodiments, as illustrated in FIG. 10, delivery device 102 mayinclude gasket or O-ring 218 for creating a seal between mounting member152 and compressor 168 which may prevent thread lock fluid from runninginto any piezoelectric crystals. In these embodiments, mounting member152 may include groove portion 153 as best illustrated in FIG. 7. Inthis example, gasket 218 is configured to fit into groove portion 153.

In some embodiments, as illustrated in FIG. 10, delivery device 102 mayinclude electrode isolator 220 configure to provide a barrier betweencompressor 168 and housing 12 and isolate certain electrodes (e.g., apositive electrode) from compressor 168.

Electrode isolator 220 may be configured to isolate compressor 168 fromhousing 112 during vibration to minimize the effect of the vibration onhousing 112 by maintaining electrical and mechanical separation.Electrode isolator 220 may be formed from rubber. Electrode isolator 220may be configured to be placed in groove 171 of compressor 12.

In some embodiments, tape made with Kapton® polyimide film may be usedto electrically isolate the positive electrodes from the groundelectrodes and other ground components.

In some embodiments, at each threaded junction, a thread locker isapplied to prevent the threads from loosening and to prevent fluidingress.

In some embodiments, delivery device 102 is a free floating resonator.That is, in this example, delivery device 102 is not fixed such as beingfixed to the housing at the tail end. Such a configuration allows for acost effective manufacture of the delivery device, because, for example,the housing may be formed of a molded plastic material.

In some embodiments, the seal components and vibration isolators areformed of a dampening or insulating material, such as a relatively softpolymeric material, for reducing or inhibiting proximal transmission ofultrasonic energy or other undesirable ultrasonic energy transmission.For example seal 216 and electrode isolator 220 may be formed ofsilicone, although a variety of materials are contemplated.

In some embodiments, system 100 may include line holders configured tohold the lines of the system together to keep the lines from twisting orknotting together. For example, as illustrated in FIG. 1, system 100includes first holder 132 and second holder 134 which are configured tokeep power line 106, vacuum line 108 and irrigation line 110 fromtwisting together. In one embodiment, line holders 132 and 134 areconfigured to slide over power line 106, vacuum line 108 and irrigationline 110. In one embodiment, line holders 132 and 134 are configured toprovide a snap fit over power line 106, vacuum line 108 and irrigationline 110. In one embodiment, holders 132 and 134 are used after vacuumline 108 and irrigation line 110 have been separated for assembly.

Referring to FIG. 1, system 100 may include connector 214 which isconfigured to removably connect to controller 104. Connector 214 may bemade of molded plastic and may include three contacts.

In some embodiments, power line 106 may include the following threeconductors: (a) a first conductor for high voltage power; (b) a secondconductor for a ground loop; and (c) a third conductor for providing asafety ground feedback and redundancy.

Generally, various components of delivery device 102 contemplated fortissue contact are formed of biocompatible and/or other suitablematerials depending upon implementation.

As illustrated in FIG. 1, delivery device 102 may be ergonomicallydesigned, adapted to be hand held (e.g., as a stylet) or otherwiseadapted to be manually operated using a single hand. In anotherembodiment, delivery device 102 may be adapted to be manipulatedautomatically or semi-automatically (e.g., as part of a robotic system).

In some embodiments, delivery device 102 is pre-tuned to a selectedultrasonic energy frequency or frequency range. For example, anultrasonic energy frequency range from about 25 kHz to about 29 kHzeffectively debrides pathologic musculoskeletal tissue (e.g., scartissue associated with a tendon) while reducing the likelihood of traumato healthy soft tissue.

As illustrated in FIGS. 1 and 11, in some embodiments, controller 104may include: tubing cassette 190 and collector 192.

As illustrated in FIG. 11, controller 104 may include: (a) housing 176;(b) command module 178 including: (i) power source 182; (ii) processor184; and (iii) signal filter 185; (c) vacuum source 186; (d) irrigationsource 188; and (e) tubing cassette 190.

In some embodiments, command module 178 includes a main unit whichpreferably includes one or more processors electrically coupled by anaddress/data bus to one or more memory devices, other computercircuitry, and one or more interface circuits. The processor may be anysuitable processor, such as a microprocessor from the INTEL PENTIUM®family of microprocessors. The memory preferably includes volatilememory and non-volatile memory. Preferably, the memory stores a softwareprogram that interacts with the other devices in system 100. Thisprogram may be executed by the processor in any suitable manner. In anexample embodiment, the memory may be part of a “cloud” such that cloudcomputing may be utilized by system 100. The memory may also storedigital data indicative of documents, files, programs, web pages, etc.retrieved from a computing device and/or loaded via an input device.

In some embodiments, command module 178 is configured to control flowfrom vacuum source 186.

In some embodiments, command module 178 is configured to control flowfrom irrigation source 188.

In some embodiments, command module 178 is configured to power deliverydevice 102.

In some embodiments, command module 178 is configured to, via userinterface 180, enable a user to select instructions. In one embodiment,command module 178 is configured to, via user interface 180, provideinstructions to a user via user interface 180.

In some embodiments, command module 178 includes signal filter 185 fordelivering a conditioned power signal (e.g., a sinusoidal power signalat a selected amplitude and frequency) to delivery device 102.

As illustrated in FIG. 11, command module 178 may include at least oneprocessor 184.

In some embodiments, controller 104 includes user interface 180. Userinterface 180 may include a touch screen system for controlling system100.

In some embodiments, controller 104 includes power source 182. Powersource 182 may include a battery, a capacitor, a transformer connectedto an external power source, such as a wall socket, combinationsthereof, or other means for providing electrical power to system 100.Power source 182 may also directly or indirectly deliver power tovarious components of controller 104 as appropriate.

In some embodiments, controller 104 includes vacuum source 186. In otherembodiments, vacuum source 186 is external or separate from thecontroller. That is, vacuum source 186 is separate from and connected tocontroller 104. Vacuum source 186 may be a peristaltic pump.

In some embodiments, controller 104 includes collector 192. Collector192 may be configured to receive detritus, fluid, or other matter beingaspirated by the aspiration flow D. Collector 192 may be a bag orcontainer. As illustrated in FIGS. 1 and 11, collector 192 may beseparate from tubing cassette 190. In other embodiments, collector 192may be maintained by, formed as a part of, or is a component withintubing cassette 190. In some embodiments, collector 192 may beconfigured to removeably connect to tubing cassette 190. In oneembodiment, collector 192 is connected to the cassette 190 using doublesided tape.

In some embodiments, controller 104 may include irrigation source 188.Irrigation source 188 may include a reservoir of irrigant (e.g.,saline). In some embodiments, the reservoir is pressurized by gravity, aplunger (e.g., a syringe), or a pump (e.g., a peristaltic pump operatedby controller 104 and optionally disposed within the housing 176) togenerate fluid flow F. In other embodiments, irrigation source 188 isseparate from system 100. In some of these embodiments, spike 113 may beconfigured to penetrate the separate irrigation source to supply fluidflow to system 100.

In one embodiment, controller 104 includes valve actuator 194. In oneembodiment, valve actuator 194 is configured to direct fluid flow F intovacuum conduits of delivery device 102, for example for flushingpurposes.

Referring to FIG. 12, in some embodiments, user interface 180 includes:(a) prime phase button 196; (b) purge phase button 198; (c) and resetphase button 200. In some embodiments, user interface 180 enables asequential operation of delivery device 102 starting with ultrasoundlevel selection 202, irrigation level selection 204, and aspirationlevel selection 206, where a user is allowed to first select ultrasoundlevel 202, then irrigation level 204, and finally aspiration level 206in sequence when operating system 100. Selections 202, 204, 206 may beilluminated sequentially, first with ultrasound level selection 202, anda user may not be enabled to make a subsequent selection until theselection at hand has been made.

In some methods of operation, the ultrasound energy and irrigant, orfluid flow, are generally delivered concurrently, while aspiration flowis delivered intermittently. For example, the ultrasound energy andirrigant flow optionally cease during aspiration and are restarted oncetreatment is reinitiated. Alternatively, irrigant flow may cease andultrasound energy continues during aspiration, although some of thebeneficial effects from using irrigant during ultrasonic treatment(e.g., continuous tip cooling and tissue emulsification, as well asothers) are potentially reduced by such operation.

In some embodiments, as illustrated in FIGS. 11 and 13A to 13C, tubingcassette 190 includes: (a) housing 208; (b) valve 209; (c) a portion ofthe vacuum line 108; (d) a portion of irrigation line 110 (designated bybroken lines).

In some embodiments, vacuum line 108 and irrigation line 110 include aplurality of interconnected segments of medical tubing, although unitaryconstructs are a potential option as well.

Tubing cassette 190 may connect vacuum line 108 to vacuum source 186 ina relatively sterile manner. For example, where vacuum source 186includes a peristaltic pump, tubing cassette 190 includes seat structure210 for causing vacuum line 108 to engage pump drive 212 of vacuumsource 186 that generates aspiration flow in vacuum line 108.

FIG. 13A illustrates an example interior side of tubing cassette 190 andFIG. 13B illustrates an example bottom side of tubing cassette 190. FIG.13C is a schematic view of an example tubing cassette 190.

In some embodiments, vacuum line 108 and irrigation line 110 may bereferred to as a tubing set.

In operation of one example embodiment, pump drive 212 of vacuum source186 (e.g., a peristaltic pump) is received in seat structure 210 suchthat vacuum line 108 is engaged against seat structure 210 between thepump drive 212 and seat structure 210. Valve 209 is engaged by valveactuator 194 to press valve 209 closed such that flow from irrigationline 110 will not travel through vacuum line 108 to delivery device 102(designated generally by a broken line rectangle in FIG. 7C). Whenvacuum line 108 is to be flushed, for example, valve 209 is released andfluid is able to flow into vacuum line 108 to the device and through thevacuum conduits. As previously referenced, the irrigant flowing throughirrigation line 110 is optionally gravity pressurized or otherwiseforced through system 100.

Assembly of system 100 includes remotely connecting delivery device 102to controller 104, where controller 104 is a separate, remote modulefrom delivery device 102. In other embodiments, delivery device 120 andcontroller 104, or portions thereof, are formed as a single unit.

In some embodiments, as illustrated in FIG. 1, controller 104 mayinclude: (a) administration line 111; and (b) spike 113 which isoperatively coupled to administration line 111.

In some embodiments, a plurality of disposable delivery devices similarto the delivery device 102 are provided with corresponding disposablecassettes, such as cassette 190 for each delivery device. Individuallypre-tuning the devices to an appropriate ultrasonic energy frequency,such as that previously described, before delivery to the user removes aneed to test and adjust power signal parameters or delivery deviceconfigurations prior to or during each procedure. Instead, in someembodiment, a single use cassette/delivery device kit is set up orconfigured prior to delivery to the end user, is then used in atreatment procedure, and is optionally discarded at the end of theprocedure, thereby reducing operation time, a requisite skill level for“tuning” system 100, and/or additional components or systems for tuningdelivery device 102. Moreover, the combination of cassette 190 anddelivery device 102 eliminates a need to sterilize equipment before aprocedure, as all components that come into contact with bodily fluidsare pre-sterilized and discarded at the end of the procedure.

In some embodiments, system 100 is used in any of a variety ofprocedures.

In some embodiments, system 100 is used to perform an ultrasound-guidedpercutaneous tenotomy.

FIG. 14 illustrates a diagrammatic view of one example of system 100being used in conjunction with ultrasound imaging system to deliverultrasonic energy to a target musculoskeletal tissue site underultrasonic imaging.

In operation, the tip portions of needle 136 and sleeve 117 may bepercutaneously inserted without having to form an incision in the skin.That is, needle 136 and sleeve 117 may help facilitate atraumatic skinand soft tissue penetration without a need for a separate incision underultrasonic imaging.

As shown in FIG. 14, advancement of the tip portions of needle 136 andsleeve 117 to target musculoskeletal tissue site 300 may be performedunder guidance of ultrasound imaging system 302 including high-frequencyultrasound transducer 304 (e.g., a frequency greater than about ten MHz)and imaging device 306. Imaging system 302, in combination with theechogenic nature of tip portion of delivery device 102, permitsintra-operative identification of target tissue site 300 in need oftreatment and an ability to percutaneously deliver ultrasonic energyfrom the exposed portion of needle 136 to target tissue site 300.

Some methods of delivering ultrasonic energy to target tissue site 300include connecting delivery device 102 to vacuum source 186, irrigationsource 188, and power source 182 of controller 104 (directly or via thecommand module 178). Ultrasonic energy is generated by sending a powersignal from command module 178 to the transducer. The ultrasonic energyis transmitted from the transducer to horn assembly 140 such that theexposed portion of needle 136 delivers ultrasonic energy at a frequencythat is pre-selected to debride musculoskeletal tissue upon percutaneousinsertion of needle 136 and sleeve 117 to target musculoskeletal tissuesite 300.

In some embodiments, user interface 180 may be operated by a user tosequentially start up delivery device 102, including initiatingultrasonic energy delivery, irrigation flow to delivery device 102, andaspiration flow from delivery device 102. Once tissue treatment iscompleted, in some embodiments, tubing cassette 190 may be removed fromcontroller 104, discarded, and replaced with a second, sterile tubingcassette (not shown) and is either pre-connected or subsequentlyconnected to a second, sterile delivery device (not shown) to sterilizesystem 100 for a new procedure.

In some embodiments, target tissue site 300 includes pathologic tissuessuch as a region of scar tissue associated with tendon 308.

In some embodiments, the pathologic tissue is identified using highfrequency ultrasonic imaging.

In some embodiments, needle 136 and sleeve 117 are delivered to targettissue site 300 under ultrasonic imaging, and ultrasonic energy isdelivered through needle 136 to debride the musculoskeletal tissue(e.g., scar tissue) forming target tissue site 300.

In some embodiments, system 100 enables a user to identify target tissuesite 300 entirely at the time of a procedure without cutting the skin ofthe patient.

As previously described, in some embodiments delivery device 102 ispre-tuned to deliver ultrasonic energy at a frequency that reduces thelikelihood of trauma to healthy soft tissue while promoting debridementof the pathologic tissue. The percutaneous, minimally invasive nature ofsuch a procedure facilitates access and treatment of such body tissue aspart of an office-based procedure under local anesthesia.

In some embodiments, after the target tissue is treated and the needleand sleeve are removed from the patient, the patient may be dischargedto home after a short period of in-office observation due to theminimally invasive nature of the procedure (e.g., as no local anesthesiawould be necessary). For example, in similarly non-invasive procedures,post-procedure pain is typically variable, but often ranges fromessentially no pain to moderately severe pain lasting less thanseventy-two hours. Thus, various embodiments of system 100 provide foran office-based procedure under local anesthesia, thereby resulting incost-savings to the patient by avoiding the costs of operating roomtime, where a patient may only need ice or cooling packs for analgesiaand edema control after the treatment.

In some embodiments, after tissue treatment is completed, tubingcassette 190 may be removed from controller 104, discarded, and replacedwith a second, sterile tubing cassette (not shown) and is eitherpre-connected or subsequently connected to a second, sterile deliverydevice (not shown) to sterilize the system 100 for a new procedure.

In some embodiments, a plurality of disposable delivery devices similarto the delivery device 102 are provided with corresponding disposablecassettes, such as cassette 190 for each delivery device. Individuallypre-tuning the devices to an appropriate ultrasonic energy frequency,such as that previously described, before delivery to the user removes aneed to test and adjust power signal parameters or delivery deviceconfigurations prior to or during each procedure. Instead, in someimplementations, a single use cassette/delivery device kit is set up orconfigured prior to delivery to the end user, is then used in atreatment procedure, and is optionally discarded at the end of theprocedure, thereby reducing operation time, a requisite skill level for“tuning” system 100, and/or additional components or systems for tuningthe delivery device 102. Moreover, the combination of cassette 190 anddelivery device 102 may eliminate a need to sterilize equipment before aprocedure, as all components that come into contact with bodily fluidsare pre-sterilized and discarded at the end of the procedure.

It should be appreciated that the system described herein is not limitedto procedure described herein, and may be used in any suitableprocedure. In some embodiments, the system described herein may be usedas a phacoemulsification device. In some embodiments, the systemdescribed herein may be used to remove plaque in the heart, veins and/orarteries. In these such embodiments, needle 136 may have a length ofabout thirty-six inches.

Although the present disclosure has been described with reference tovarious examples, persons skilled in the art will recognize that changesmay be made in form and detail without departing from the spirit andscope of invention. For example, various modifications and additions canbe made to the exemplary embodiments discussed without departing fromthe scope of invention. While the embodiments described above refer toparticular features, the scope of invention also includes embodimentshaving different combinations of features and embodiments that do notinclude all of the above described features.

1. An ultrasonic energy delivery device configured to deliver ultrasonicenergy to a musculoskeletal tissue site, the device comprising: a singlecomponent comprising a horn configured to receive energy generated by atransducer and a precipitation-hardened stainless steel needle.
 2. Thedevice of claim 1 further comprising a processor configured to activatethe transducer, wherein the processor includes stored instructions thatwhen executed cause the device to deliver ultrasonic energy at afrequency selected to debride the musculoskeletal tissue.
 3. The deviceof claim 1, wherein the horn includes a tip portion that has an inwardlyslanted portion configured to receive brazing material.
 4. A systemconfigured to deliver ultrasonic energy to a musculoskeletal tissuesite, the system comprising: a memory device containing instructions; aprocessor in communication with the memory device; a delivery devicecomprising: a horn; and a precipitation-hardened stainless steel needle;wherein said horn and said needle comprise a single component whereinexecution of the instructions by the processor causes the transducer togenerate ultrasonic energy at a pre-determined frequency suitable fordebriding musculoskeletal tissue.
 5. The system of claim 4 furthercomprising a fluid source, wherein the delivery device further comprisesa fluid delivery conduit for delivering fluid from the fluid source tothe musculoskeletal tissue site.
 6. The system of claim 4, wherein thedelivery device further comprises an aspiration conduit configured toremove detritus from the musculoskeletal site.
 7. The system of claim 4,wherein the delivery device includes a housing having a clear portion.8. The system of claim 4, wherein the stainless steel needle is a fullyhardened hypodermic needle.